Panels › Obstetrics/Gynecology › Product code MQF · Class 2
Catheter, Assisted Reproduction
Regulation 884.6110
1510(k)s in 12 months (53 all time)
0recalls in 12 months (36 all time)
13recalls that name a 510(k)
Top companies in MQF
| Company | 510(k)s | Recalls |
|---|---|---|
| Tenderneeds Fertility LLC | 0 | 19 |
| Cook Incorporated | 7 | 5 |
| Fertility Technology Resources, Inc. | 3 | 6 |
| Smiths Medical ASD, Inc. | 0 | 6 |
| Cook Ob/Gyn | 5 | 0 |
| Cooper Surgical | 4 | 0 |
| CooperSurgical, Inc. | 3 | 0 |
| Kitazato Corporation | 3 | 0 |
| Allwin Medical Devices, Inc. | 2 | 0 |
| Fertiligent, Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 1998 | K983591 | INTRATUBAL TRANSFER SETS Cook Ob/Gyn | MQF |
| Dec 21, 1998 | K983590 | GIFT CATHETER SET/S Cook Ob/Gyn | MQF |
| Dec 16, 1998 | K983587 | HYSTEROSCOPIC GIFT CATHETER SETS Cook Ob/Gyn | MQF |
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